EMB-001 is a patented combination product comprised of two FDA-approved medications, the cortisol synthesis inhibitor metyrapone and the benzodiazepine oxazepam. The innovation is based on insights into the physiological responses to stress in addiction.

The goal of addiction treatment is long-term abstinence, and to accomplish this, one must minimize relapses. There are three well-characterized causes of relapse: stress-induced (such as family conflict), cue-induced (environmental triggers like seeing drug paraphernalia) and drug-induced (even small exposures renewing addiction). In addition to stressors, both cues and drug exposure lead to stress responses. Therefore, it is theorized that modulating stress response pathways may reduce all 3 sources of relapse.

By combining two medications that work on different aspects of the physiological stress response, at lower doses, EMB-001 may maximize potential efficacy more than either drug used alone. A therapy that breaks these barriers and results in long term abstinence and recovery would be a significant contribution to the treatment of a broad range of addictions.

Clinical Development

Embera completed a randomized, double-blind, placebo-controlled, single- and multiple-dose, Phase 1 safety and pharmacokinetics (PK) study in smokers. EMB-001 met the primary goals of the study. Treatment was well tolerated and PK results suggested that twice-daily dosing may provide appropriate exposure for efficacy. In addition, exploratory smoking measures showed encouraging results to support a planned Phase 2a study in tobacco use disorder. Results from the Phase 1 study were presented at the Society for Research of Nicotine and Tobacco (SRNT) Annual Meeting, the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, and other scientific conferences in 2016. Based on these results, Embera is advancing the EMB-001 cocaine use disorder and tobacco use disorder programs to the next stage of clinical development.

Previously, Embera completed a randomized, double-blind, placebo-controlled pilot clinical study of EMB-001 in cocaine-dependent (per DSM-IV) subjects. EMB-001 treatment resulted in significantly reduced cocaine use, compared to placebo, by the end of the 6-week study. Additionally, treatment with EMB-001 led to significant reductions in cocaine craving at several time points during the study and was well-tolerated over the six-week treatment period. Results were published in Psychopharmacology in 2012.

The Company’s clinical development program is also supported by positive preclinical studies in which EMB-001 reduced self-administration of nicotine, as well as cocaine and methamphetamine, in relevant models of addiction. In the nicotine study, EMB-001 also demonstrated a statistically significantly greater effect relative to varenicline (Chantix®), the clinical market leader for smoking cessation efficacy. Cocaine studies of EMB-001 established the drug combination’s efficacy at doses which, when tested as monotherapy, had no effect.